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Seong Yong Park
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FP03 - Immuno-biology and Novel Immunotherapeutics (Phase I and Translational) (ID 151)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP03.02 - Interim Analysis of Neoadjuvant Chemoradiotherapy and Durvalumab for Potentially Resectable Stage III Non-Small Cell Lung Cancer (NSCLC) (ID 804)
00:00 - 00:00 | Author(s): Seong Yong Park
- Abstract
- Presentation
Introduction
Although definitive concurrent chemoradiotherapy (CRT) is considered standard of care for most stage III NSCLC patients, neoadjuvant-CRT (N-CRT) followed by surgery is an accepted practice with a potential survival benefit. Regarding synergistic effects of combining PD-1/PD-L1 blockade to CRT, we designed a two-stage phase Ib trial (ACTS-30) which assesses the safety and feasibility of the combination of N-CRT with durvalumab (PD-L1 inhibitor) in potentially resectable stage III NSCLC (ClinicalTrials.gov identifier: NCT03694236).
Methods
Patients with histologically confirmed, potentially resectable stage III NSCLC were eligible. N-CRT comprised intravenous weekly paclitaxel 45 mg/m2 and carboplatin AUC 2 with radiotherapy of 45 Gy in 25 fractions and durvalumab (Day 1 and 29, 1500mg) during 5 weeks and patients who completed N-CRT subsequently underwent surgery. After surgery, one year of adjuvant durvalumab was planned (every 4 weeks, 1500 mg). The primary objective was to determine the safety and tolerability of N-CRT + durvalumab regimen. The trial was composed of two-stages and the first stage included 9 patients and the trial was planned to proceed to the second stage (n = 21) if treatment-related adverse events (TRAEs) grade≥3 occurred in less than 50% of patients. The secondary endpoints are objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), clinical or pathological downstaging rate, pathologic complete response (pCR) rate, and major pathologic response (MPR) rate. The exploratory analyses including immune marker assessment by FACS, whole-exome sequencing, single-cell RNA sequencing, and multispectral immunohistochemical staining using the specimen of pre-treatment, after surgery, and after recurrence will be performed.
Results
At the data cut-off (25th-Feb-2020), a total of 14 patients were enrolled. The median age was 66; 50% were male, and 50% were adenocarcinoma histology including two EGFR mutations. Since there was only one grade 3 TRAE (i.e., neutropenia) during the first stage, the trial entered the second stage. Overall, the grade 3 or more rate of TRAE was 7% (1/14). Currently, 11 patients underwent surgery (R0 resection) while one patient experienced cardiac pacemaker infection grade 3 (not considered as TRAE) and was not able to undergo surgical resection and two others are awaiting surgery. There was no postoperative in-hospital mortality. Among eleven resected patients, the pCR rate and MPR rate were 36.4% (3/11) and 72.7% (8/11), respectively. When excluding two EGFR mutant, the MPR rate was 88.9% (8/9).
Conclusion
These early data suggested that the N-CRT regimen with immunotherapy in stage III NSCLC was safe and feasible and had the potential to provide clinical benefit. The trial is ongoing and the final results and the biomarker analyses will be provided in the future congress and scientific journal.
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P19 - Locoregional and Oligometastatic Disease - Oligometastatic Disease (ID 129)
- Event: WCLC 2020
- Type: Posters
- Track: Locoregional and Oligometastatic Disease
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P19.03 - Operative Outcomes of Local Consolidation with Cytoreductive Surgery for Oncogenic-Driven Advanced NSCLC (ID 1875)
00:00 - 00:00 | Author(s): Seong Yong Park
- Abstract
Introduction
With the advent of targeted therapy, the survival in oncogenic-driven advanced non-small cell lung cancer (NSCLC) has been improved. Still, all patients who received the targeted therapy finally recur due to resistance to the targeted agent. The local consolidative therapy with targeted therapy has been studied recently, but these studies mainly focused on radiation therapy, and the role of surgery has not been studied yet. This retrospective study was performed to investigate the operative outcomes for oncogenic-driven advanced NSCLC after targeted therapy as a form of local consolidation.
Methods
Between March 2018 and July 2020, 44 patients received the pulmonary resection and mediastinal lymph node dissection for stage IIIB-C or IV NSCLC after targeted therapy. In some patients, the other metastatic lesions were treated with radiation therapy or surgery prior to pulmonary resection. The operative outcomes were analyzed retrospectively.
Results
The median age of patients was 59 years-old (range, 28~75), with 15 (34.1%) male patients. The initial stages were as following; 4 IIIBs, 1 IIIC, and 39 IVs. The initial mutations were 30 EGFRs, 8 ALKs, and 1 ROS1. The initial metastasis sites were as following; 10 brains, 6 bones, 7 lymph nodes, 6 intrathoracic organs, and 17 multiple organs. The median interval from the initiation of targeted therapy to the operation was 10.7 (range, 2.1~46.3) months. The types of operations were as follows; 37 lobectomies, 2 bi-lobectomies, 3 segmentectomies, and 2 wedge resections. The complete resection was achieved in 40 (90.9%) patients. There was no operative mortality. Complications were developed in 15 patients: 5 prolonged air leakages, 3 chyle leakages, 2 vocal cord palsies, 1 broncho-pleural fistula, 1 acute kidney injury, 1 acute lung injury, 1 pneumonia, and 1 pneumothorax. Four patients showed complete remission on the surgical specimen. The median postoperative follow-up periods were 7.8 months (0.4~28.8). During the follow-up periods, 14 patients suffered from the disease progression: 6 lung lesions, 4 brains, 1 bone, 1 pleura, and 2 others. Two patients died during the follow-up periods. Among 32 patients with EGFR mutation, 12 patients showed additional mutations, such as T790M, and targeted agents were changed into another targeted agent in 9 patients after the operation.
Conclusion
The pulmonary resection for advanced NSCLC after targeted therapy was feasible, and the surgical specimen obtained from the operation could be used for further planning of targeted therapy. The long-term benefits of pulmonary resection on survival after targeted therapy have to be studied in further trials.
